To investigate the effects of Palmaria palmata on cholesterol and psychological stress in Japanese participants with dyslipidemia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

LDL cholesterol

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Administration of placebo twice daily for 8 weeks

Interventions/Control_2

Administration of Palmaria palmata (2g/day) twice daily for 8 weeks

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Participants who are 20-year-old or older, and younger than 60-year-old at the time of obtaining informed consent
2)Participants whose fasting serum LDL colesterol levels are more than 120 mg/dL
3)Participants who can visit the medical institution according to schedule
4)Participants who are able to understand the study and willing to provide written informed consent

Key exclusion criteria

1)Participants whose fasting serum triglyceride levels are more than 400 mg/dL
2)Participants in pregnancy, lactation and scheduled pregnancy period
3)Participants who have made a blood donation within 2 (component blood donation), 4 (200mL), or 12 (400mL) weeks
4)Participants who are attending other studies or attended other studies within past 4 weeks
5)Participants with present heart, liver, kidney or thyroid disorders
6)Participants with a history of cardiac disorder
7)Participants with diabetes
8)Participants with allergy to the study foods
9)Participants who have been felt ill by blood collection
10)Participants with heavy use of alcohol
11)Participants with heavy smoking
12)Participants with irregular eating habits
13)Participants who are taking drugs, foods for specified health use or functional foods which could affect this study
14)Participants with a history of receiving a gastrointestinal surgery
15)Participants who are deemed to be unsuitable by the investigator